VistOR MS

GUDID 01816835022051

VistOR MS LED, DUAL IL-CR, SURGICAL LIGHT

MEDICAL ILLUMINATION INTERNATIONAL INC.

Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system

• Primary Device ID: 01816835022051
• NIH Device Record Key: 1d93e32c-149a-4b3a-85fd-a99d43a84958
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistOR MS
• Version Model Number: NVSD2CD2
• Company DUNS: 093357739
• Company Name: MEDICAL ILLUMINATION INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816835022052 [Primary]
GS1	01816835022051 [Package]; Contains: 00816835022052; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100388

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-08-01

Devices Manufactured by MEDICAL ILLUMINATION INTERNATIONAL INC.

• 01816835023898 - Vu-E: 2024-04-10 Vu-E, TRIO, SURGICAL LGHT W/MONITOR ARM
• 01816835024314 - SYSTEM TWO LED: 2024-01-26 SYSTEM TWO LED, TRIO, IL-CR & DUO SURGICAL LIGHT
• 01816835024307 - SYSTEM TWO LED: 2024-01-10 SYSTEM TWO LED, DUO,IL-CR SURG LIGHT W/MON ARM
• 00816835023950 - IsoLED Mini LED HL: 2023-10-10 IsoLED mini LEDHL, Standard, w/Mounting Clips
• 01816835023966 - IsoLED Mini LED HL: 2023-10-10 IsoLED mini LEDHL, Attached to Safety Glasses
• 01816835023973 - IsoLED Mini LED HL: 2023-10-10 IsoLED mini LEDHL, Attached to Headgear
• 01816835023980 - IsoLED II LED HL: 2023-10-10 IsoLED II LED HL, Standard
• 01816835023997 - IsoLED II LED HL: 2023-10-10 IsoLED II LED HL, w/ AC Power Pack